Status:
COMPLETED
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Lead Sponsor:
Foundation for Liver Research
Conditions:
Crohn's Disease With Perianal Fistulas
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease
Detailed Description
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
Eligibility Criteria
Inclusion
- proven Crohn's disease
- Single or multiple draining perianal fistulas
Exclusion
- Abscesses
- Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
- active viral infection
- significate cardiovascular dysfunction
- Pregnancy, Lactation
- Surgical bowel resection to be expected within 6 months
- Positive stool culture for enteric pathogens
- Total parental nutrition
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00736983
Start Date
September 1 2008
End Date
December 1 2011
Last Update
April 17 2012
Active Locations (13)
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1
AMC
Amsterdam, Netherlands
2
VU
Amsterdam, Netherlands
3
Deventer ziekenhuis
Deventer, Netherlands
4
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands